Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy

August 14, 2024 updated by: Asmaa Ali, Ain Shams University
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • AinShams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from July 2022 till December 2024

Description

Inclusion Criteria:

  • Breast cancer patients aged 18 years old or more
  • Female patients
  • Histologically proven invasive breast cancer
  • Histologically proven HR-positive and HER2-negative breast cancer
  • Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3.
  • Adequate hematological and organs function
  • Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment

Exclusion Criteria:

  • - Male breast cancer patients
  • Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
  • Prior treatment with any CDK 4/6 inhibitor.
  • History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
  • Have active bacterial or fungal infection, or detectable viral infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metastatic breast cancer patients
metastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line
Drug: CDK4/6 Inhibitor
CDK4/6 inhibitor in first and second lines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effect
Time Frame: 2 years
assess the toxicity profile
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 years
PFS in patient receiving CDK4/6i in Egypt
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

August 10, 2024

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDKTOX2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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